Early Phase Drug Development

Our Phase I Unit features:

  • 100+ beds
  • Three 6-8 bed intensive procedural units
  • Cat-5 hurricane secure building
  • Generator: services entire building
  • EVAC helipad
  • On-site security
  • State-of-the-art security system
  • Security cameras throughout facility
  • Pull-cord emergency devices
  • Limited key-card access
  • Visiplex synchronized study clocks
  • Gated, secure patient parking
  • Temperature monitoring for critical equipment
  • Secured, double-locked Pharmacy
  • Exam and procedure rooms
  • Dedicated CLIA waived Lab
  • Nursing stations to directly monitor each IPU
  • Dosing room with recliners
  • Baxter IV pumps and poles
  • Monitoring rooms with phone and internet access
  • Screening and waiting rooms
  • Secured server with cloud back-up
  • WiFi access
  • 4 separate patient bedrooms
  • Patient kitchen and dining areas
  • Recreation room
  • Televisions throughout facility
  • Patient showers and locker rooms
  • Handicap accessible restrooms
  • 4 crash carts: defibrillators, AEDs, oxygen and suction
  • Multiple -20° and -70° freezers
  • Multiple 2-8° refrigerators
  • Refrigerated and non-refrigerated centrifuges
  • Incubator
  • Drug prep work bench
  • 2 Laminar flow hoods
  • Hazardous chemical storage
  • Blood pressure machines
  • ECG machines
  • Pulse oximetry

 

Early Phase Capabilities:

  • Clinical Pharmacology
      • First-in-Human (First in Man)
      • SAD and MAD PK Studies
      • Healthy vs. Patient population
      • ADME
      • Special Populations
        • Renal Impairment
        • Hepatic Impairment
        • Age, gender, etc.
      • Drug Interactions
      • Cardiac Safety (e.g. TQTc study)
  • PK/PD
      • Dose selection
      • Efficacy v. Safety
  • Biopharmaceutics
    • Bioavailability/Bioequivalence (BA/BE)
    • Food Effect

 

Phase I Trial Experience: Healthy Volunteers

  • Bioavailability/Bioequivalence (BA/BE)
  • Ascending Dose
  • Absorption Distribution Metabolism & Excretion (ADME)
  • QT/QTc Safety
  • PK/PD
  • Food Effect (Fed/Fasted)
  • Vaccines
  • Drug-to-Drug Interaction
  • Maximum Tolerated Dose
  • Drug Transfer
  • Single/Multiple Dose
  • Patch Testing
  • Devices

 

Phase I Trial Experience: Special Populations

  • Hepatic Impairment
    • Hepatic impairment, including, but not limited to, Hepatitis A, B, and C
    • Hepatic classifications as Child-Pugh A, Child-Pugh B, and Child-Pugh C (mild, moderate, and severe)
  • Renal Insufficiency
    • Classification as Mild, Moderate, and Severe, including Dialysis
  • Type I Diabetes
  • Type II Diabetes
  • Elderly
  • Hypertension
  • Pre/Postmenopausal
  • Obesity
  • Immunology
    • Plaque Psoriasis
    • Rheumatoid arthritis
    • Lupus
  • Psychiatric
    • Schizophrenia

 

Therapeutic Areas

  • Cardiology/Vascular Diseases
  • Dental and Oral Health
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Hematology
  • Hepatology (Liver, Pancreatic, Gall Bladder)
  • Immunology
  • Infectious Diseases
  • Musculoskeletal
  • Nephrology
  • Neurology
  • Nutrition and Weight Loss
  • Obstetrics/Gynecology (Women’s Health)
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Otolaryngology (Ear, Nose, Throat)
  • Pediatrics
  • Podiatry
  • Psychiatry/Psychology
  • Pulmonary/Respiratory Diseases
  • Rheumatology
  • Urology
  • Vaccines

 

In addition to the Phase I experience listed above, we serve ALL Specialties and ALL Indications.